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Probiotics for Inflammation in Pediatric Chronic Pain

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Recruiting
CT.gov ID
NCT05141890
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
25.2
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index >=85th percentile.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Lactobacillus Plantarum
 N/A

Detailed Description

The purpose of the current study: (1) examine whether a 7-11 week supplement of a single-strain probiotic (Lactobascillus Plantarum, Lp299v) reduces systemic inflammation; (2) determine whether reductions in systemic inflammation will correlate with reductions in pain, disability, mood impairment and changes in mechanical pain threshold and mechanical pain sensitization; (3) Explore whether reductions in systemic inflammation will correlate with reductions in other outcomes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Probiotics for Inflammation in Pediatric Chronic Pain
Actual Study Start Date :
Apr 25, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotic

Participants will be given the probiotic supplement Lp299v. The supplement is taken by mouth in the form of capsules. Participants will undergo a screening visit. After 7-11 weeks of taking Lp299v, they will return for their final visit. Blood will be drawn before and after the 7- 11 week intervention.

Dietary Supplement: Lactobacillus Plantarum
Dietary Supplement: Lp299v. Lp299v is a commercially available probiotic supplement manufactured and distributed by Next Foods.
Other Names:
  • Lp299v

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in systemic inflammation - CRP [7-11 weeks]

      Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement.

    Secondary Outcome Measures

    1. Change in Worst Pain intensity [7-11 weeks]

      Change in worst pain intensity (based on a 0-10 numeric rating scale) over the past 2 weeks after 7-11 weeks of probiotic supplement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female biological sex

    2. 13-17 years of age

    3. Body Mass Index ≥85th percentile for sex and age

    Exclusion Criteria:

    1. Probiotic (or prebiotic) supplement use or antibiotic use within the past month

    2. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids

    3. Patients who have had a poor response to blood draw or immunizations in the past

    4. Chronic use of medications known to alter gastrointestinal function or inflammation (e.g. metformin, non-steroidal anti-inflammatory medications)

    5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

    6. Use of illicit drugs

    7. Females who are pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Wisconsin Milwaukee Wisconsin United States 53185

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keri Hainsworth, Associate Professor, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT05141890
    Other Study ID Numbers:
    • 1679041
    First Posted:
    Dec 2, 2021
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Inflammation
    Chronic Pain

    Study Results

    No Results Posted as of Jun 24, 2022